United States Recalls
Consumer recalls from the FDA, CPSC, NHTSA, and USDA FSIS.
Chrysler (FCA US, LLC) - Vehicle Can Exceed the Speed Rating of the Tires
Loss of vehicle control increases the risk of a crash.
Svnntaa Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapmen...
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. The bed rails do not meet structural stability or retention strap requirements, posing a fall hazard. Furthermore, the bed rails' push pins and push pin holes are incorrectly sized, posing a laceration hazard.
Rainbow Wall Toys Recalled Due to Risk of Serious Injury or Death from Choking H...
The recalled toys violate the mandatory safety standard for children's toys because the drumstick that is attached to the xylophone component has a spherical end that can pose a choking hazard.
General Motors, LLC - Do Not Drive: Front and/or Rear Wheels May Lock Up
Front or rear wheel lockup increases the risk of a crash.
EVLWZL and Gunugu Mattresses Recalled Due to Risk of Serious Injury or Death fro...
The mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
Favoto Bicycle Helmets Recalled Due to Risk of Serious Head Injury; Violate Mand...
The recalled helmets violate the mandatory safety standard for bicycle helmets because they do not comply with the positional stability, labeling and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.
ZMC Group Recalls Multiple Light Up Toys Due to Risk of Serious Injury or Death ...
The recalled toys violate the mandatory safety standard for children's toys because the toy contains button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
Analemma Water Bottles Recalled Due to Risk of Serious Injury or Death from Lace...
The recalled water bottle's inner glass liner can break, posing a risk of serious injury or death from laceration and ingestion hazards.
Allura Imports Recalls Youth Sweatshirts with Bobcat Logo and Drawstrings Due to...
The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children from strangulation. The sweatshirts are in violation of the federal regulations for children's upper outerwear and present a substantial product hazard.
Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head ...
The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the positional stability and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.
Chrysler (FCA US, LLC) - Power Transfer Unit May Fail and Cause a Loss of Drive ...
A failed PTU may result in a loss of drive power or vehicle rollaway, increasing the risk of a crash or injury.
EEMB USA Recalls Battery Pouches Due to Risk of Serious Injury or Death from Bat...
The lithium coin batteries are in pouches that are not child-resistant as required under Reese's Law. If a child swallows button cell or coin batteries, the ingested batteries can cause serious injuries, including internal chemical burns and death.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol ...
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
52USA brand POPPING BOBA; STRAWBERRY FLAVOR; Net wt: 7 lb (3.2kg); Ingredients D...
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
i-STAT EG7+ cartridge; List Number: 03P76-25;
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, car...
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
KLG, Kesar Mukhwas, perishable, 24 months, flexible plastic, 200 gm, 81881202220...
Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14.
Top Lid Label: Einstein Bros Bagels Honey Almond Double-Whipped Shmear. Cup La...
Undeclared allergen (almond).
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
catheter may experience resistance when being advanced over the guidewire
52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredient...
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, lab...
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF)...
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7811...
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.